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General Motors

QUALITY SYSTEMS BASICS AUDIT


SUPPLIER: DATE:
SUPPLIER DUNS NO:
SUPPLIER LOCATION: AUDITOR:
SUPPLIER CONTACT:
CONTACT EMAIL: EMAIL:

This audit corresponds to the current Quality Systems Basics requirements as defined in the QSB presenta
revised in March, 2009. This audit applies to all suppliers regardless of which revision of the QSB presenta
was used for training. The new presentation contains several new requirements which are included in this
This audit supersedes any previous audit and presentation revisions. If a QSB audit was conducted using t
audit form approved for use at that time and prior to this revision date, it is should not be necessary to repe
entire audit unless it has been longer than 2 years.

AUDIT SUMMARY
POTENTIAL AUDIT
KEY STRATEGIES STATUS IS CORRECTIVE ACTION REQU
SCORE SCORE

1.0 FAST RESPONSE NR


0 0
CONTROL OF
2.0
NONCONFORMING PRODUCT NR
0 0
3.0 VERIFICATION STATIONS NR
0 0
4.0 STANDARDIZED OPERATIONS NR
0 0
5.0 OPERATOR TRAINING NR
0 0
ERROR PROOFING
6.0
VERIFICATION NR
0 0
7.0 LAYERED PROCESS AUDITS NR
0 0
8.0 RISK REDUCTION NR
0 0
9.0 CONTAMINATION CONTROL NR
0 0
10.0 SUPPLY CHAIN MANAGEMENT NR
0 0
11.0 MANAGING CHANGE NR
0 0

TOTAL SCORE 0 0
Audit status is equal to
AUDIT STATUS the lowest color status of NR
the above strategies.

Note: YELLOW and RED status on any question requires corrective actions.
QSB Audit form 07.04 Rev 20090213
Follow-up may be done on site or via E-mail; at the auditor's discretion.

Application of this audit's requirements, including requirements added after


December 31, 2008, and the results to the supplier's status is at Supplier Quality's discret

STATUS FOR INDIVIDUAL QUESTIONS

R 0 - No implementation: Corrective Action Required


R 1 - Written implementation plan: Corrective Action Required, or
R 2 - In place, not followed: Corrective Action Required.
Y 3 - YELLOW: requirement partially implemented
G 4 - GREEN: requirement met
Note: Potential & Audit Scores are entered automatically from audit sheet..

QSB Audit form 07.04 Rev 20090213


Y SYSTEMS BASICS AUDIT

uality Systems Basics requirements as defined in the QSB presentation


es to all suppliers regardless of which revision of the QSB presentation
ation contains several new requirements which are included in this audit.
it and presentation revisions. If a QSB audit was conducted using the
and prior to this revision date, it is should not be necessary to repeat the
an 2 years.

AUDIT SUMMARY
IS CORRECTIVE ACTION REQUIRED

ED status on any question requires corrective actions.

QSB Audit form 07.04 Rev 20090213


be done on site or via E-mail; at the auditor's discretion.

udit's requirements, including requirements added after


results to the supplier's status is at Supplier Quality's discretion.

e: Potential & Audit Scores are entered automatically from audit sheet..

QSB Audit form 07.04 Rev 20090213


QUALITY SYSTEMS BASICS AUDIT
# EVIDENCE REQUIRED LOOK FOR… COMMENTS SCORE R/Y/G
1.0 FAST RESPONSE: PROBLEM SOLVING, COMMUNICATION and LESSONS LEARNED
Is there a system in place to immediately respond to significant internal and external quality failures?
Daily leadership meeting ON THE SHOP FLOOR:
Addresses significant Quality concerns. 1) Prior to the meeting review the board:
Owned by Manufacturing - for report out dates and statusing to see if any are past due,
Designates owners. statused appropriately with detail explaining missed dates.
Assigns report out dates. - Ask if there are any new issues.
Cross-functional, multilevel attendees. 2) Observe the report out process and verify that the Problem Solving
report format is used to document & communicate the status of the
issue.
3) Sign-in Sheet identifying cross-functional & plant wide support is in
1.1 attendance daily. NR
4) Natural owners are assigned to problems
5) Internal issues are included and addressed to the same Fast
Response criteria.(e.g. LPA findings, Verification Station or Dock
Audit issues, Supplier Issues)
6) Who leads the meeting & is there a designated back up person.

Exit Criteria Follows the problems steps ON THE SHOP FLOOR:


including Lessons Learned, LPA, Error 1) Exit criteria represents the 6 "Core" steps of problem solving plus
proofing and updates to Work tracking for LPA, Error proofing, updates to Work Instructions,
Instructions, PFMEA & Control Plan. PFMEA & Control Plan.
2) Method of communicating problems to all Key Stake holders (e.g.
Timing for each of the criteria Quality Alert, Temporary Work Instructions, By-Pass Procedure)
established, A guideline for timing for each of the exit criteria.
3) Red items have a planned date to go green, some detail
1.2 Problems are communicated to the 4) explaining why and the next step. NR
appropriate employees. Problems are not closed until all criteria is met.
5) Follow an issue from Fast Response Tracking Board through the
Overall status represents the worst 6) exit criteria confirming corrective action is in place & all
condition or overall planned timing has documentation has been updated.
been exceeded

The concerns are communicated to the ON THE SHOP FLOOR


appropriate employees & Fast 1) Quality Q or other method to track FR performance is tracked,
Response Process performance is posted and up to date.
1.3 tracked 2) Compare Quality "Q" to Fast Response Tracking Form for NR
Quality status is posted. correlation. Do the metrics show improvement?

Is there a defined process for Problem Solving leading to root cause identification and elimination?
A defined process for Problem Solving 1) Completed Problem Solving forms used across the plant for
including a standard for documenting internal, customer and supplier issues.
the tools used for root cause 2) Standard forms (PPSR or equivalent) used with a format that
identification. follows the core '6 Steps' of problem solving
(Define, Contain, Root Cause, Correct, Validate, Institutionalize)
3) Forms identifying root cause( Drill Deep, 5 Why, Fishbone, Cause
& Effect, etc...)
4) Changes to PFMEA and Control Plan indicating root cause
elimination.
5) Evidence of cross-functional team approach.
1.4 ON THE SHOP FLOOR ASK: NR
6) Supervisors/Team or Group Leaders and OPERATORS about
their role in Problem Solving
BEST PRACTICES:
- Forms completed on shop floor by Supervisors/Team or Group
Leaders (non-engineering staff) with team input.
- A standard training method for all Team Members/Leaders

Is there a system in place to capture information that supports continuous improvements to all operations/processes?
A system to capture and institutionalize 1) Review Lessons Learned procedure & forms.
lessons learned. 2) Documented sources that capture lessons learned such as Fast
Response, Problem Solving Documents, Continuous Improvement
Process, APQP, Risk Reduction team checklist, Read-Across,
1.5 Customer re-allocations (tool moves). NR
3) Completed Lessons Learned information which is easily
retrievable by all who need the information. (e.g. Master FMEA,
Read Across, Electronic forms or database).

A disciplined approach to problem 1) APQP Program check list reviews lessons learned.
prevention using lessons learned. 2) Continuous improvement team notes and agendas
3) Method which assures implementation supported by evidence of
1.6 review dates, distribution lists, or posted Lessons Learned. NR
(e.g. Active Drill Wide, Read-Across tracking)

QSB Audit form 07.04 5 of 15 Rev 20090213


QUALITY SYSTEMS BASICS AUDIT
# EVIDENCE REQUIRED LOOK FOR… COMMENTS SCORE R/Y/G
Leadership reviews Lessons Learned 1) Leadership notes or agenda indicating Lesson Learned system is
process to assure implementation. reviewed such as through a LPA or internal systems audit.
1.7 2) Regularly scheduled reviews documenting steps of NR
institutionalizing lessons learned. (e.g. Read-Across)

SCORE / POTENTIAL 0 0

QSB Audit form 07.04 6 of 15 Rev 20090213


QUALITY SYSTEMS BASICS AUDIT
# EVIDENCE REQUIRED LOOK FOR… COMMENTS SCORE R/Y/G
2.0 CONTROL OF NONCONFORMING MATERIAL
Is there a system in place to ensure products that do not conform to specified requirements are prevented from unintended use?
A consistent tagging system is used to ON THE SHOP FLOOR
identify suspect and nonconforming 1) Color coding of scrap containers, hold tags, scrap labels, in-
product. process tags, travelers, routers, etc…
2) If red tags are used for both scrap and suspect material, tag must
have disposition.
3) Suspect tags should have last operation performed.
2.1 BEST PRACTICE:
NR
System is Stoplight visual management where red indicates scrap
or and yellow indicates suspect product/material. Green or any
other color (except yellow or red) indicates acceptable product.

Nonconforming and suspect material ON THE SHOP FLOOR:


are segregated in properly identified 1) Segregation areas are identified and/or foot printed,
2.2 areas. 2) Scrap bins, rework tables, hold areas, etc…are identified/foot NR
printed

Containment form or nonconforming 1) Containment worksheet or equivalent,


material form identifies expected
quantity and locations of suspect ON THE SHOP FLOOR:
material. 2) There are standards in place for Color coding of scrap containers
Product in containment properly for containment issues.
identified. Red = Non-conforming Product
2.3 Yellow = Suspect Product NR
Green = After Breakpoint, Conforming Product
3) Std Containers for W.I.P. and Finished good are not used for
sorting and placement of defective material.
4) Nonconforming material area and associated documents.

Is there a nonconformance quality alert and notification procedure that meets customer requirements?
The organization’s nonconformance Documents to ensure communication and follow-up activities occur
alert notification and containment as required such as:
process includes communication and 1) An Alert document that is used:
action for all stakeholders: - For external and internal issues
- Customer(s) - To establish tasks, time line,& communications
- Tier-2s, etc. necessary to meet customer requirements.
2.4 - Internal stakeholders - Defines the problem & the standard NR
2) Internal/external distribution and notification
3) Customer contact list
4) Certified shipment log
5) Tiered supplier contacts and certified shipment documents.

Product removed from the approved ON THE SHOP FLOOR: (if live example is available)
process flow for repair or rework: 1) Look for evidence of reintroduction, at or prior to point of removal.
- Has Approved Work Instructions 2) Verify that reintroduction includes all downstream checks such as
- Is reintroduced into the process at or error proofing. (All control plan inspections & tests to be performed)
prior to the point of removal If it cannot be reintroduced into the process, verify that an
- Is traceable through an identifier 3) approved (Quality Manager) documented rework and inspection
- Is released using a defined process procedure is followed.
and authority. Look for an identifier such as serial number or special marking that
2.5 4) can be traced back to the supplier record to show what was done NR
and when.
Form to release product with authorized signature and approved
5) inspection of product
BEST PRACTICE: The limit for the number of times repaired
is not more than 2 times with a tracking method.

Scrap is prevented from unintended 1) Procedure and method for materials/parts designated as scrap to
use, tracked and reduced through on- ensure it is properly identified and kept from being reintroduced
going continuous improvement. back into the normal material flow. (e.g. destruction, paint, locked
2.6 container) NR
2) Performance metrics and goals established to reduce scrap at all
levels of the operation.

Leadership involvement in internal and 1) Periodic summary reports


2.7 external spill, containment and 2) Material Review Board information and signatures NR
communication activities
SCORE / POTENTIAL 0 0

QSB Audit form 07.04 7 of 15 Rev 20090213


QUALITY SYSTEMS BASICS AUDIT
# EVIDENCE REQUIRED LOOK FOR… COMMENTS SCORE R/Y/G
3.0 VERIFICATION STATIONS
Is there at least one Verification Station in the process? (If a GMPT supplier, C.A.R.E. must be implemented.)
A procedure, operator instructions or ON THE SHOP FLOOR
other documentation which focuses on 1) How process information is monitored and information is relayed
Building Quality in Station through upstream to those that need to know and react:
Feedback from the process. - Station staffed for 100% inspection with a defect tally sheet
listing defects to look for.
- Automated testing and list of part characteristic/defect
checks being verified. (fault codes, defect description)
- Control chart noting reaction to out-of-control conditions.

2) When C.A.R.E. is in place, documentation requires identification


3.1 and inspection of customer satisfaction items: warranty issues, NR
pass-through items, PR/R issues, past Quality problems, high RPN
items, etc...

BEST PRACTICE:
- Look for a minimum of 1 at the end of each product assembly
line, or between departments such as molding, paint, assembly,
which provides feedback to upstream operations.

Procedure or instructions that require ON THE SHOP FLOOR:


immediate reaction when alarm limit is Look for evidence in the documentation stating:
reached. (Past Customer defects shall
1) When and who to call,
always have an Alarm limit of '1'. All
2) Who responded and when
C.A.R.E. items must be '1). 3) The immediate fix, corrective action taken and breakpoint.
4) Document that describes when a problem is to be escalated.
3.2 Responses to alarms are documented. 5) Escalation identifies who is the next person to be called and their NR
contact information?
Escalation procedure is followed for BEST PRACTICE:
repeat defects or no response. - Alarm & Escalation is applied at each step of the operation where
defect detection exists.

Corrective actions implemented as a ON THE SHOP FLOOR


result of Verification Station activities.
1) Assignment of problem solving activities related to station data
2) Tracking sheet displayed in the area on the shop floor.
3.3 Team reports out weekly and the status 3) Problem solving documentation NR
is reviewed during the 4) Problem Report out Schedule
leadership/support staff walk through.

Feed Back data from downstream ON THE SHOP FLOOR


customers is documented and 1) Performance Graphic or report card showing (i.e. calendar days-
performance is tracked at the red/green) feedback from downstream customers and details.
inspection point. 2) Graphic or report card showing findings at the station for
3.4 communication to upstream processes/suppliers. NR
3) FTQ or scrap analysis showing improvement trend, reduction of
events/defects over time.

Leadership reviews Verification Stations ON THE SHOP FLOOR


activities and results. 1) Sign-in sheet, and meeting assignment log.
Daily management walk through or 2) Evidence the station operator reports results and responses to
3.5 meetings at selected stations. calls NR
3) At the meeting, a review of the current findings and the previous
shift to determine if the escalation process is effective.

SCORE / POTENTIAL 0 0

QSB Audit form 07.04 8 of 15 Rev 20090213


QUALITY SYSTEMS BASICS AUDIT
# EVIDENCE REQUIRED LOOK FOR… COMMENTS SCORE R/Y/G
4.0 STANDARDIZED OPERATIONS
WORKPLACE ORGANIZATION
Is there a systematic approach to utilize and maintain Workplace Organization?
Procedures or operator instructions for ON THE SHOP FLOOR:
cleaning and maintaining organized 1) Ask a Team Member to explain the 5S process.
areas. Procedures or instructions or 2) Does the 5S process focus on waste elimination?
other documentation that support a 3) Documentation that defines:
systematic approach to standardization - what is to be in a work cell,
of workplace organization. - how it is to be labeled and guides for label location.
4) Standards that display placement and identification of material,
equipment, tools, aisles, hazards, including storage of personal
belongings.
4.1 5) Start-up/Shut down task list, 5S or TPM Check List, identifying NR
frequency, time, and tools required.
6) FIFO - Material is staged with oldest material to be used first and
newest to be used last.
7) Visual aids used to assist in the process flow.
8) A process for updating workplace organization standards at some
frequency.

Clean, organized work areas. Items in ON THE SHOP FLOOR:


areas labeled, foot printed or otherwise 1) Ask if the Production, Maintenance, Quality, Material and office
identified. areas have documented workplace organization standards.
2) Look for evidence of an established audit frequency and that it is
4.2 followed. NR
3) A countermeasure sheet or equivalent includes issue found, owner,
action, and date for correction.

STANDARDIZED WORK INSTRUCTIONS


Is there a system in place to develop standardized work instruction (methods and sequence) for all operations?
Standardized Work Instructions are ON THE SHOP FLOOR
posted at or near all operations where 1) Ask the Team Member where their standardized Work instructions
there are human operators. are located.
2) Instructions are located for quick and easy reference. (close to the
workstation)
3) Documentation of required PPE, availability and use at the
workstation.
4.3
4) Instructions include Work Elements & Times (element-walk-wait),
NR
Work Flow Sequence (operator path), Standard in-process stock,
Operation Cycle Time, Takt Time (Customer and Actual).
5) Visuals accurately represent the workstation layout and work
sequence.

All affected operators are trained in the 1) Evidence that operators are trained in the use of Standardized
use of Standardized Work Instructions Work Instructions.

4.4 ON THE SHOP FLOOR: NR


2) Ask team member how the Standardized Work Instructions are
used.

Procedure requires cross-functional teams ON THE SHOP FLOOR


and continuous improvement. 1) Ask the Team Member/Leader their level of involvement in
developing their standardized work.
2) Verify Team Leaders, Team Members, Group Leader original
signature is on the document.
3) Ask if the Group Leader understands their role in the support of
4.5 standardized work by acting as a liaison to the support NR
organizations.
4) Ask the Team Leader if there is a process (formal or informal) for
teams to seek agreement for job element sequence within the
team and across all shifts and crews.

QSB Audit form 07.04 9 of 15 Rev 20090213


QUALITY SYSTEMS BASICS AUDIT
# EVIDENCE REQUIRED LOOK FOR… COMMENTS SCORE R/Y/G

OPERATOR INSTRUCTIONS
Is there a systematic approach to develop Operator Instructions for all work.
Procedure, instructions or other ON THE SHOP FLOOR:
documentation that requires 1) Operator instructions in or near work areas that are accessible to
development of operator instructions for operators.
all work. 2) Compare instructions to work performed by operators.
OBSERVE 3 full cycles of the job in station &Verify:
- That the Major Steps (What), Key Points (HOW),
and Reason (WHY) are followed.
- (All key points shall have a reason Why)
3) Ask the Team Member how they know they have made good part.
Quality checks are included.
4.6 4) Specific tool requirements are listed at the operation. NR
5) Verify critical items such as torque or Customer Safety
6) requirements are specified in the document.
BEST PRACTICE:
Major Steps (What), Key Points (HOW), and Reason (WHY) are
properly explained. (What is the outcome if the step is not
performed as described)

Verify, maintain and update operator instructions as processes/products change.


Procedure, instructions or other ON THE SHOP FLOOR:
documentation that requires 1) Review revision history of operator instructions.
implementation and revision of operator 2) Compare revision levels of operator instructions with PFMEA or
instructions. Control Plan revision levels.
4.7 3) Check to see if it is marked up, signed, and dated around the NR
timing of a recent customer problem or CI action item.
4) Evidence of appropriate operator training records when revisions
were made.

Is there a system in place for Gage control.


Procedure and forms to document 1) Documented procedure and gage/fixture use instructions.
process. 2) Calibration sticker.
Compliance to customer requirements 3) Operator gage training to the current gage instruction.
(GM 1925) for both internal & external 4) Gage master device.
gage providers. 5) Gage certification frequency.
6) Gage R@R.
4.8 Gage instructions updated to current BEST PRACTICE: NR
product and process level. Last Part Checked should be held for confirmation of last known
good part at a frequency of at minimum of 1 per shift. Best
practice would be to retain hourly samples for each inspection,
retained for the entire shift or previous 8 hours.

SCORE / POTENTIAL 0 0

QSB Audit form 07.04 10 of 15 Rev 20090213


QUALITY SYSTEMS BASICS AUDIT
# EVIDENCE REQUIRED LOOK FOR… COMMENTS SCORE R/Y/G
5.0 STANDARD OPERATOR TRAINING
Is there a system to define a standard training method, minimum content and tracking for all operators new to an
operation and/or those in need of refresher training?
A standard method that defines the 1) Evidence of a graduating step approach such as the 4 Step (Job
steps trainers are trained and certified Instruction Training) process and are provided the opportunity to
to, in order to properly train operators practice the new skill or knowledge.
on their job. - Prepare, Demonstrate, Try-out performance, Follow-Up.
2) Documentation to show who is certified to train.
5.1 NR
ON THE SHOP FLOOR:

3) Ask operators how they are trained.

Standard operator training records 1) Training record that documents training of procedures and overall
document specific areas of training job knowledge to:
such as safety, quality record keeping, - Work safely (guards, start-up shut down, lock out)
gaging, workplace organization - Perform proper record keeping (production/quality)
5.2 responsibilities. - Understand work place organization responsibility NR
- Quality requirements (containment, red-bins, andon, etc)

2) Records are available and easily retrieved.

Specific Job instruction training is 1) Individual Job training record with dates and trainer signoff for each
documented for each operator showing job.
all jobs trained on, skill or knowledge 2) Record indicates the steps in training & skill/knowledge level
level of the job, who trained them and achieved for each job:
when. 3) Follow-up includes the trainer audits employee to standard work
instructions, verifies quality & productivity within shift and again
approximately one day later.
5.3 NR
ON THE SHOP FLOOR:
4) Verify a new operator is following Standardized Work Instructions &
know the quality and productivity requirements.
5) Training for the job is documented on their individual record.

Records reflecting training status of all ON THE SHOP FLOOR:


operators posted at the operation 1) Operator Tracking Sheets or equivalent posted at all operations or
indicating they are trained to the current work area.
work instruction change level. 2) All operators listed including supplemental employees.
3) Review training dates and tracking sheet revision dates.
BEST PRACTICE:
- Chart showing cross training/certification level in a cell such as a
flexibility chart.
5.4 - Look for a job rotation plan or log. How often does team rotate? NR
- The number of Team Members certified per station should
support the Job Rotation Plan.
- If it does not, look for a plan such as a Flexibility Chart 2x2 or 4x4
matrix, that shows the status, actual vs planned number certified
per station that is being used to maintain job rotation.

Training records for supplemental or 1) Documentation, scheduling, and tracking forms for supplemental
temporary employees that document operator refresher training.
5.5 refresher training if they have not NR
performed that job within the last three
months.

SCORE / POTENTIAL 0 0

QSB Audit form 07.04 11 of 15 Rev 20090213


QUALITY SYSTEMS BASICS AUDIT
# EVIDENCE REQUIRED LOOK FOR… COMMENTS SCORE R/Y/G
6.0 ERROR PROOFING VERIFICATION
Is there a system in place to verify that error proofing/ detection devices used in manufacturing and assembly are functioning properly?

Documentation and evidence that ON THE SHOP FLOOR:


indicates devices are verified at least 1) Documentation (verification logs) of device verification at a
once per day. minimum of once per day & are easily accessible.
6.1 2) Reaction plan includes who is notified and actions to be taken. NR
Reaction to failures and corrective 3) Containment and corrective action documentation for failures.
actions are documented.

Error Proofing device locations shall be 1) Master list of all devices that prevent/detect the manufacture or
6.2 documented. assembly of nonconforming product. NR
Management periodically reviews 1) Verification failures on Fast Response Tracking Sheets, Layered
6.3 results of verification. Audit, Management Review agenda, Verification tracking forms NR
available.
SCORE / POTENTIAL 0 0
7.0 LAYERED PROCESS AUDITS
Is there a system in place to verify the documented manufacturing/assembly process through layered audits?
A defined Layered Process Audit 1) Written Procedure
procedure that is owned by 2) Audit & work instructions
7.1 manufacturing. 3) Counter measure process NR
4) Owned by Manufacturing

All levels of the organization participate 1) Audit Schedule showing level of participation and frequency.
in Layered Process Audits at 2) Evidence that ALL layers of the organization perform regularly
established frequencies. scheduled standardized audits. Plant Manager should be monthly,
Shift Leaders and Management Support Staff - Weekly, Group
7.2 Leader-Team Leaders-Daily. NR
3) Tracking to ensure every work station is evaluated on regular
basis.

Audit Check sheet includes: 1) Quality Focused checks for past customer failures. (i.e. Assigned
Workstation, Quality (Customer Focus), at Fast Response, for PRR or Liaison Report issues, error-proofing
and System high risk items. verification, etc...)
2) Workstation Specific check items (Review of actual work performed
by Team Members to standardized work instructions, 5S-WPO,
Rotation Log, Training, etc..)
7.3
3) Work Station and Quality Focused items are checked by all
NR
auditors.
4) System Specific items (Preventative Maintenance, Business Plan
reviews, Shop Floor Management standards, etc..)

Process specific audits are performed 1) Verification in the Layered Process Audit under system specific
7.4 (CQI 9, 11, 12, Weld Audit, Chrome items that, where applicable, Audits for special processes are NR
Audit, Paint Process Audit etc.) performed.
System to review and document the 1) Results reviewed with team members & area supervisors
results of the audit. 2) Evidence and documentation of immediate corrective action for
nonconformance. (Items corrected immediately)
All deviations are recorded on the 3) Countermeasure list with responsibility and dates for items that
check sheet. could not be corrected immediately.
7.5 4) Review of counter measure process at least once per week. NR
5) When appropriate nonconformance is added to Fast Response or
C.A.R.E.
BEST PRACTICE:
Check that the Audits are verified by the next level Supervisor.

Addition of Layered Process Audit 1) Lessons Learned system, documentation.


7.6 issues to the Lessons Learned system. NR
Audit results are summarized and 1) Reports or graphics that are reviewed by management.
7.7 reviewed by manufacturing site NR
leadership.
SCORE / POTENTIAL 0 0

QSB Audit form 07.04 12 of 15 Rev 20090213


QUALITY SYSTEMS BASICS AUDIT
# EVIDENCE REQUIRED LOOK FOR… COMMENTS SCORE R/Y/G

8.0 RISK REDUCTION


Is there a system in place for reducing the risk of all production processes by reducing the highest RPN values?
PFMEA’s shall be developed and 1) PFMEA available for all part numbers and all operations, especially
maintained by cross-functional teams high risk such as labeling and rework.
for all manufacturing processes and 2) Accurate Severity/Occurrence/Detection Ratings with Valid RPN
support functions as required by the numbers and revision dates with some correlation to known
8.1
AIAG manual. problems (PRRs, etc…).
NR
3) Are updated on a regular basis (living documents).

Cross-functional teams have periodic 1) Cross-functional team agenda or other evidence of RPN reduction
reviews of PFMEA and coordinate RPN activities.
reduction activities? 2) Documentation that frequency and prioritization of reviews is based
on customer input, process capability, process changes, AIAG
guidelines, etc…
3) Review checklists, agendas or equivalent that assure adequate
PFMEA review (all operations/processes (paint, heat treat,
material handling, labeling, rework/repair, etc…) are included and
8.2 accurate. NR
- All process controls are included.
- Detection ratings are accurate.
- Occurrence ratings are analyzed using data (SPC, FTQ,
Quality Gate, C.A.R.E.*, Scrap, Layered Process
Audits* results)

Proactive approach to reduction of 1) Top RPN list,


highest RPN values has been 2) Tracking charts
8.3 implemented. Top RPN list with action 3) Cross-functional team minutes noting improvement actions and NR
plans. completion details.
There is a Reverse PFMEA (Pro-active 1) Cross-functional team conducts a process walk through audit .
Error Proofing) process in place. 2) Action Plan.
3) Does this cover all High Risk Parts.
4) Are the findings driven back into Process Flow, PFMEA, Control
8.4 Plan, Work Instructions as applicable. NR
5) Have Occurrence/Detection numbers been revised.

Evidence of past quality issues and 1) Revision date of PFMEA to address error proofing and verification
corrective actions that have been of past failures.
implemented. 2) Action plans with target completion dates
3) Team validates the new Occurrence and Detection rankings and
8.5
resultant RPN.
NR
4) Error proofing is verified per the Error Proofing Verification*
process.

Management review of the RPN 1) Management review agenda/minutes


reduction process, training 2) Cross-functional team training and individual qualifications
8.6 requirements, and tracking of RPN reviewed and verified annually. NR
reduction results. 3) Evidence of documentation to track improvements. (Trend Chart,
Process change validation, Layered Process Audit)

SCORE / POTENTIAL 0 0

QSB Audit form 07.04 13 of 15 Rev 20090213


QUALITY SYSTEMS BASICS AUDIT
# EVIDENCE REQUIRED LOOK FOR… COMMENTS SCORE R/Y/G
9.0 CONTAMINATION CONTROL
Is there a system in place to control contamination when appropriate?
Sediment: Procedures for the 1) Procedure to include:
measurement and monitoring - Methods defining sediment collection
- System to measure to a standard
9.1 - Application using statistical method to monitor and control NR
2) Site leadership review of results for compliance and continuous
improvement

Sediment: Procedure for maintaining 1) Process controls to maintain:


the processes to control the affect of Parts Washers, Deburrs, metal working fluid systems, dunnage
9.2 sediment and part storage, air and fluid probes NR
2) If there is a clean room, standards are established and adhered to.

Extra Parts: Procedure for controlling 1) Method to prevent extra parts or materials that may fall into or stick
extra parts. to products which are not intended as part of the finished product.
such as:
Magnetic tools, Shielding, Fixture Orientation, Rollovers and
9.3 Dump Stations, Magnetic wrench. NR
2) Methods are verified through error proof verification and/or Layered
Process Audits.

Dirt in Paint: Procedure for maintaining 1) Procedure to include:


the processes to control and prevent - Dirt training awareness
dirt contamination. - Post paint handling methods
- Application using statistical method to monitor and control
9.4 2) There is an active dirt reduction team and action plan. NR
3) Site leadership review of results for compliance and continuous
improvement

Retained material in Castings: 1) Procedure to include:


Procedure to measure, monitor, and - Methods to measure retained material (i.e. Tunk test)
improve retained material in castings. - Verification that measurements are taken and results are
documented.
- Any non-conformance to standards are documented and
corrective actions are implemented.
9.5 - Processes/Equipment are verified through error proof NR
verification, preventative/predictive maintenance, and Layered
Process Audits.
2) Site leadership review of results for compliance and continuous
improvement

Corrective actions for customer 1) Review customer complaint history for contamination related
complaints related to contamination. complaints.
2) Verify complaints are reviewed at Fast Response, have
documented problem solving, and corrective actions have been
9.6 implemented. NR
3) Contamination issue and corrective actions are added to Layered
Process Audits.

SCORE / POTENTIAL 0 0
10.0 SUPPLY CHAIN MANAGEMENT
Is there a systematic process in place to control suppliers?
Procedures and work instructions to Procedures that require supplier audits to support sourcing
select and evaluate suppliers. decisions, quality systems, special processes, and product/process
specific evaluations.
1) - Potential supplier assessments
10.1 2) - Quality Systems Basics audit NR
3) - Special Processes such as Heat Treat, Plating, and Coating.
4) - Labeling PFMEA/Control Plan

Procedure for evaluating compliance to 1) Compliance to Customer specific requirements such as GP-9, GP-
customer specifications and 12, etc.
requirements 2) Process Control Plan Audits
10.2 3) Gaging Audits NR
4) Problem Solving with disciplined method for root cause analysis
such as 5-Why.

Measurement and validation system for Methods to determine ranking of Key suppliers with reviews of
key suppliers performance supplier performance to specified goals.
1) Key Supplier list with defined metrics/goals
2) Reviews of supplier performance with a defined procedure and
10.3 actions for poor performing suppliers. NR
3) Method or process in place to communicate problems and track
corrective action.

SCORE / POTENTIAL 0 0

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QUALITY SYSTEMS BASICS AUDIT
# EVIDENCE REQUIRED LOOK FOR… COMMENTS SCORE R/Y/G
11.0 MANAGING CHANGE
Is there a systematic process in place to control product, process, or source changes?
A documented procedure for monitoring 1) A plant process change form utilized to document all changes.
and controlling all product, process or 2) Change Forms are controlled through a Document Control
source changes. Process. (e.g. tracking log sheet, revision numbering system,
11.1 approval process) NR
3) Both planned and emergency changes covered by the change
procedure.

Procedure to establish a defined 1) A standardized communication procedure and form to control and
Production Trial Run (PTR) process. monitor all Production Trial Runs that documents each step of the
process & records all approvals and results.
2) Build readiness reviews required to authorize the start of the trial
11.2 run production process. NR
3) Quality reviews documented to release product for PTR shipment
and verification process has returned to normal production.

A parts banking strategy/procedure for 1) Defined procedure and responsibility for the execution of long term
identifying, protecting and retrieving long storage of parts or materials?
term storage of parts or materials. 2) Established guidelines for protective packaging for parts and
11.3 material. NR
3) Quality reviews to established inspection criteria for the authorized
release of banked parts and material.

Procedure to authorize bypassing 1) Written procedure to include:


processes How product quality standards are maintained
Method for proper authorization to enter and exit the process
Defines when the process is initiated and returned to normal
Standardized work and operator training are documented
11.4 2) A Worksheet is used to track each process that is in bypass. NR
3) The bypassed process is frequently audited for compliance (Best
Practice is hourly)
4) Bypassed processes are documented in PFMEA and Control Plan

SCORE / POTENTIAL 0 0

SCORING CRITERIA
0 No implementation: Corrective Action Required
1 Written implementation plan: Corrective Action Required
2 In place, not followed: Corrective Action Required
3 YELLOW: Requirement partially implemented
4 GREEN: Requirement met
NR NR: Not Reviewed
Note: Enter appropriate score based on R Y G score criteria and hit enter. Correct color will appear in R/Y/G cell.

Not Reviewed is used when:


1) Immediate focus does not include the strategy. Give future review date in comments box.
2) Plan to review in the future. Give future review date in comments box.
3) Question or strategy does not apply to this supplier. Explain in comments box.

QSB Audit form 07.04 15 of 15 Rev 20090213